Efficacy: 12 years and older

Designed to stay in your body 40% to 50% longer16

Half-life refers to how long it takes for the body to eliminate half the dose of a product.13

A pharmacokinetic comparison of ADYNOVATE vs ADVATE was conducted in 26 children and adults (12 years and older) prior to beginning prophylactic treatment with ADYNOVATE.16

In the study in children and adults (12 years and older), the extended half-life of ADYNOVATE allowed it to stay in the body 40% to 50% longer than ADVATE [Antihemophilic Factor (Recombinant)] depending on the lab test used.16

For representational purposes only. Half-life may vary from person to person.

PEGylation was deliberately chosen for the creation of ADYNOVATE*16

Polyethylene glycol, or PEG, is attached to the full-length ADVATE molecule in a process called PEGylation.1

Twice-weekly prophylaxis was proven to reduce ABR

Study Design

The safety, efficacy, and PK of ADYNOVATE® [Antihemophilic Factor (Recombinant), PEGylated] were evaluated in a 6-month study that compared the efficacy of a twice-weekly prophylactic treatment regimen with on-demand treatment and determined hemostatic efficacy in the treatment of bleeding episodes.1

A total of 137 previously treated male patients (12 to 65 years old) with severe hemophilia A received at least 1 infusion with ADYNOVATE. Twenty-five of the 137 subjects were adolescents (12 to less than 18 years of age).1

Adolescents and adults (12 years and older) in this study were given ADYNOVATE prophylaxis twice-weekly at a dose of 40-50 IU/kg (n=120) or on-demand treatment (n=17) with ADYNOVATE at a dose of 10-60 IU/kg.1

Study Goal

The primary study goal was to compare the ABR between the prophylaxis versus on-demand treatment groups.2

Prophylaxis helped some patients stay bleed-free

During the 6-month study in children and adults (12 years and older)1:

Per-protocol population consisted of all patients who were assigned to the prophylactic group treated with their originally assigned dose for the entire duration of study participation and who fulfilled the protocol compliance requirements.

SELECTED IMPORTANT RISK INFORMATION

You can have an allergic reaction to ADYNOVATE.Call your healthcare provider right away and stop treatment if you get a rash or hives, itching, tightness of the throat, chest pain or tightness, difficulty breathing, lightheadedness, dizziness, nausea or fainting.

The common side effects of ADYNOVATE are headache and nausea. Tell your healthcare provider about any side effects that bother you or do not go away.

Effective coverage against bleeds

During the 6-month clinical study in children and adults (12 years and older) receiving twice-weekly prophylaxis treatment1:

Median is defined as the middle number in a list of numbers arranged in numerical order.14ABR=annualized bleed rate, the number of bleeds that occur over a year.
IQR=interquartile range; the range of values of the variable in a statistical distribution that lies between the upper and lower quartiles.15

SELECTED IMPORTANT RISK INFORMATION

Your body may form inhibitors to Factor VIII. An inhibitor is part of the body's normal defense system. If you form inhibitors, it may stop ADYNOVATE from working properly. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to Factor VIII.

Effective bleed control when you need it

When bleeds did occur, the majority were controlled with a single infusion of ADYNOVATE® [Antihemophilic Factor (Recombinant), PEGylated].1

In the clinical trial, bleeding episodes controlled:

*Excellent defined as full relief of pain and objective signs of bleeding cessation; Good defined as definite pain relief and/or improvement in signs of bleeding.1

SELECTED IMPORTANT RISK INFORMATION

You should not use ADYNOVATE if you:

Are allergic to mice or hamster protein

Are allergic to any ingredients in ADYNOVATE or ADVATE [Antihemophilic Factor (Recombinant)]

Tell your healthcare provider if you are pregnant or breastfeeding because ADYNOVATE may not be right for you.

You should tell your healthcare provider if you:

Have or have had any medical problems.

Take any medicines, including prescription and non-prescription medicines, such as over-the-counter medicines, supplements or herbal remedies.

Have any allergies, including allergies to mice or hamsters.

Have been told that you have inhibitors to factor VIII (because ADYNOVATE may not work for you).

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Indications

ADYNOVATE is an injectable medicine that is used to help treat and control bleeding in children and adults with hemophilia A (congenital Factor VIII deficiency). Your healthcare provider may give you ADYNOVATE when you have surgery. ADYNOVATE can reduce the number of bleeding episodes when used regularly (prophylaxis).

ADYNOVATE is not used to treat von Willebrand disease.

DETAILED IMPORTANT RISK INFORMATION

You should not use ADYNOVATE if you:

Are allergic to mice or hamster protein

Are allergic to any ingredients in ADYNOVATE or ADVATE [Antihemophilic Factor (Recombinant)]

Tell your healthcare provider if you are pregnant or breastfeeding because ADYNOVATE may not be right for you.

You should tell your healthcare provider if you:

Have or have had any medical problems.

Take any medicines, including prescription and non-prescription medicines, such as over-the-counter medicines, supplements or herbal remedies.

Have any allergies, including allergies to mice or hamsters.

Have been told that you have inhibitors to factor VIII (because ADYNOVATE may not work for you).

Your body may form inhibitors to Factor VIII. An inhibitor is part of the body’s normal defense system. If you form inhibitors, it may stop ADYNOVATE from working properly. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to Factor VIII.

You can have an allergic reaction to ADYNOVATE.
Call your healthcare provider right away and stop treatment if you get a rash or hives, itching, tightness of the throat, chest pain or tightness, difficulty breathing, lightheadedness, dizziness, nausea or fainting.

The common side effects of ADYNOVATE are headache and nausea. Tell your healthcare provider about any side effects that bother you or do not go away.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

ADVATE [Antihemophilic Factor (Recombinant)] Important Information

Indications

ADVATE is a medicine used to replace clotting factor (factor VIII or antihemophilic factor) that is missing in people with hemophilia A (also called “classic” hemophilia).
ADVATE is used to prevent and control bleeding in adults and children (0-16 years) with hemophilia A.
Your healthcare provider may give you ADVATE when you have surgery.
ADVATE can reduce the number of bleeding episodes in adults and children (0-16 years) when used regularly (prophylaxis).

ADVATE is not used to treat von Willebrand disease.

DETAILED IMPORTANT RISK INFORMATION

You should not use ADVATE if you:

Are allergic to mice or hamsters.

Are allergic to any ingredients in ADVATE.

Tell your healthcare provider if you are pregnant or breastfeeding because ADVATE may not be right for you.

You should tell your healthcare provider if you:

Have or have had any medical problems.

Take any medicines, including prescription and non-prescription medicines, such as over-the-counter medicines, supplements or herbal remedies.

Have any allergies, including allergies to mice or hamsters.

Have been told that you have inhibitors to factor VIII (because ADVATE may not work for you).

Your body may form inhibitors to factor VIII. An inhibitor is part of the body’s normal defense system. If you form inhibitors, it may stop ADVATE from working properly. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to factor VIII.

You can have an allergic reaction to ADVATE.Call your healthcare provider right away and stop treatment if you get a rash or hives, itching, tightness of the throat, chest pain or tightness, difficulty breathing, lightheadedness, dizziness, nausea or fainting.

Side effects that have been reported with ADVATE include: cough, headache, joint swelling/aching, sore throat, fever, itching, dizziness, hematoma, abdominal pain, hot flashes, swelling of legs, diarrhea, chills, runny nose/congestion, nausea/vomiting, sweating, and rash.Tell your healthcare provider about any side effects that bother you or do not go away or if your bleeding does not stop after taking ADVATE.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.